Job Description Summary

Regulatory Affairs Coordinator II provides administrative support to the UCC Regulatory Affairs Team including as needed database management and support of regulatory affairs activities and registration process. This position is able to use good judgment in order to complete all tasks in a timely manner with attention to detail and accuracy. Able to act independently and evaluate unusual situations as necessary. Maintain confidentiality in all matters. Able to maintain a high level of organizational, administrative and business skills along with excellent communication and interpersonal skills.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Coordinate and administer the Regulatory Change Management process. Evaluate each request to ensure appropriate for department, compile all requested information, and compile summaries of responses to various requests.
• Administrates systems for the regulatory team.
• Works with Regulatory Affairs Specialists to assist with preparation of regulatory affairs documentation utilized to support various registrations, STEDs, and Dossiers.
• Must manage volume of word processing and correspondence to complement the needs of Regulatory Affairs. This includes memos, letters, status reports, certificates, FDA documents, position descriptions, presentations, overheads, etc.
• Responsible for ordering department supplies and purchase orders for the department
• Creates requisitions using the applicable systems
• Responsible for updating standard operating procedures (SOP), work instructions (WI), and policies as appropriate.
• Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
• Coordinate and upload regulatory documentation to EDMS.

• High School diploma or equivalent experience in a regulated environment
• 1-3 Years Regulatory Affairs or Quality Assurance experience with medical technology companies

• Proficient in using Microsoft Word, Access, Excel and Outlook.
• Strong communication and project management skills.
• Must be able to balance multiple tasks.
• Attention to details.
• Knowledge of Medical Device Quality Systems and Good Documentation Practices.
• Able to be Notary Public.